Hybrid breast implant and tissue expander, methods of making and use of same

Abstract

An implant includes a first container and a plurality of members disposed in the first container. The implant can be made by attaching a member to a second container disposed in the first container and inserting the second container in the first container. The implant can be used by disposing the implant into a subject and adjusting a volume of a fluid in the implant. Additionally, a tissue expander includes an outer container; and an inner container disposed in the outer container and comprising: a reticulated frame comprising a plurality of struts which interconnect; a void disposed between the struts in the reticulated frame; and a projection connected to the struts to cover the void.

What is claimed: 
     
         1 . A tissue expander comprising:
 an outer container; and   an inner container disposed in the outer container and comprising:   a reticulated frame comprising a plurality of struts which interconnect;   a void disposed between the struts in the reticulated frame; and   a projection connected to the struts to cover the void.   
     
     
         2 . The tissue expander of  claim 1 , wherein the tissue expander further comprises a valve disposed on the outer container, the valve comprising an internal path which is configured to communicate fluid into or out of the interior of the outer container and to selectively seal the tissue expander. 
     
     
         3 . The tissue expander of  claim 1 , wherein the inner container has a plurality of voids, and the voids are arranged in a repeating pattern. 
     
     
         4 . The tissue expander of  claim 1 , wherein a shape of the void is polygonal, round, square, rectangular, or irregular. 
     
     
         5 . The tissue expander of  claim 1 , wherein the struts and the void of the reticulated frame are arranged in a closed polyhedral pattern. 
     
     
         6 . The tissue expander of  claim 1 , wherein the struts are arranged on a surface of the inner container, and an interior of the inner container is a hollow cavity. 
     
     
         7 . The tissue expander of  claim 1 , wherein the projection comprises an opening through which an interior of the inner container is in fluid communication with an interior of the outer container. 
     
     
         8 . The tissue expander of  claim 1 , wherein the inner container is free-floating in the outer container. 
     
     
         9 . The tissue expander of  claim 1 , wherein the inner container is attached to the outer container. 
     
     
         10 . The tissue expander of  claim 1 , wherein the struts have a thickness which is greater than a thickness of the projection. 
     
     
         11 . The tissue expander of  claim 1 , wherein the reticulated frame has a shape which is a spheroid or ellipsoid. 
     
     
         12 . The tissue expander of  claim 1 , wherein the inner container is flexible and is configured to flex in response to a compressive force or a stretching force, and to return to an original shape in response to removal of the compressive force or the stretching force such that the outer container retains a primary shape. 
     
     
         13 . The tissue expander of  claim 1 , wherein the outer container and inner container independently comprise an elastomer. 
     
     
         14 . A process for making a tissue expander, the process comprising:
 disposing a polymer on a mandrel;   forming an inner container from the polymer on the mandrel, the inner container comprising:   a reticulated framework comprising an interconnected network of struts; and   a plurality of projections disposed on and extending outwardly from the reticulated framework, the struts having a thickness which is greater than a thickness of the projections;   curing the polymer of the inner container on the mandrel;   removing the inner container from the mandrel; and   disposing the inner container in an outer container to make the tissue expander.   
     
     
         15 . The process of  claim 14 , further comprising disposing an opening in the struts, the projections, or a combination thereof such that an interior of the inner container is in fluid communication with an interior of the outer container. 
     
     
         16 . The process of  claim 14 , further comprising attaching a filling tube to the outer container. 
     
     
         17 . The process of  claim 14 , further comprising disposing a patch as a seal on the outer container, inner container, or a combination. 
     
     
         18 . A method for expanding tissue, the method comprising:
 disposing the tissue expander of  claim 1  in tissue; and   filling the tissue expander with a fluid to expand the tissue.   
     
     
         19 . The method of  claim 18 , wherein the tissue expander is disposed between muscle and skin. 
     
     
         20 . The method of  claim 18 , wherein the tissue expander is flexible and is configured to flex in response to a compressive force or a stretching force, and to return to an original shape in response to removal of the compressive force or the stretching force such that the outer container retains a primary shape.